Endotracheal tube and connector unit

ABSTRACT

A device for the endotracheal administration of a gaseous anesthetic has a flexible tube for insertion into the trachea, including an inflation cuff integrally joined with and surrounding the tube adjacent the distal portion thereof, and an inflation duct formed in the tube and isolated from the interior thereof, which duct extends from the cuff to proximal portions of the tube and through which inflation air may be supplied to the cuff. The proximal portions of the tube are integrally joined with a rigid connector having a valve member in air communication with the inflation duct for controlling the supply of inflation air to the cuff.

[451 May 8,1973

[ ENDOTRACHEAL TUBE AND CONNECTOR UNIT [75] Inventor: Allen Chen, Belleville, Mich.

[73] Assignee: Lorton Laboratories, Ltd., New

York,N.Y.

[22] Filed: Sept. 24, 1970 [21] Appl. No.: 75,163

[52] US. Cl ..128/35l, 128/349 B, 128/349 BV [51] Int. Cl. ..A6lm 25/00 [58] Field of Search ..l28/349 B, 349 BV,

[56] References Cited UNITED STATES PATENTS 12/1970 McWhorter ..128/349B 8/1949 Myller ....l28/349BUX FOREIGN PATENTS OR APPLICATIONS 810,517 3/1959 Great Britain "128/351 OTHER PUBLICATIONS Brochure of The Shiley Disposable Tracheostomy Tube, copyright September, 1970.

Primary Examiner-Aldrich F. Medbery Attorney-Curtis, Morris & Safford [57] ABSTRACT A device for the endotracheal administration of a gaseous anesthetic has a flexible tube for insertion into the trachea, including an inflation cuff integrally joined with and surrounding the tube adjacent the distal portion thereof, and an inflation duct formed in the tube and isolated from the interior thereof, which duct extends from the cuff to proximal portions of the tube and through which inflation air may be supplied to the cuff. The proximal portions of the tube are integrally joined with a rigid connector having a valve member in air communication with the inflation duct for controlling the supply of inflation air to the cuff.

16 Claims, 17 Drawing Figures PATENTEDHAY 81m 3,731,691

SHEU 1 [1F 4 INVENTOR 0911622, S. Chen BY I M; 744% ATTORN EN DOTRACHEAL TUBE AND CONNECTOR UNIT The present invention relates to devices for the endotracheal administration of a gaseous anesthetic.

At present, the endotracheal administration of gaseous anesthetics during surgery is accomplished through a simple flexible tube, such as of rubber or plastic, ofa length and diameter suitable to the size and length of the trachea of the patient being anesthesized. Certain of such tubes have been provided with an inflatable cuff adjacent the distal portions thereof, which cuff, when filled with air, is inflated to a bulbous shape for retaining the tube in position after the tube has been inserted into the trachea. This collar or cuff is generally inflated through an inflation tube which is connected at one end to the cuff and extends to a position adjacent the proximal of the tube where it terminates in a laterally extending inflation arm provided with a plug to seal the mouth thereof. In some cases the plug is simply a removable closure member, although it has been proposed that the plug be an integral part of the inflation arm through which a hypodermic needle may be inserted for supplying inflation air to the cuff.

The arrangements of the previously proposed endotracheal tubes which utilize an inflation cuff are subject to several serious objections. Typically, the inflation tube is a separate element independent of the endotracheal tube and thus adds substantially to the mass which must be inserted in the trachea. The added mass tends to interfere with surgical procedures that sometimes are required in the trachea during operations. Further problems arise with regard to the closure mechanism used for the inflation tube. Where a closure plug is utilized, leaks often occur thereabout, so that the cuff deflates and loses its capacity to maintain the tube in proper position within the organ. The addition, it is difficult to prevent loss of air during filling since the syringe used to supply the air must be removed from the mouth of the inflation duct for insertion of the closure member. To prevent loss of air during this period the physician generally clamps the inflation tube until the plug is properly inserted. This requires an additional time consuming step and an additional surgical implement. Finally, in the event that the cuff is overinflated the physician cannot accurately or conveniently control release of air with the plug closure member.

Where a resealing or plug valve adapted to be pierced by the needle of a syringe is used, the needle often inadvertently pierces the wall of the inflation arm, thereby rendering the tube useless and perhaps injuring the physician. Further, when it is desired to remove the tube from the body of the patient, evacuation of the cuff by means of the hypodermic syringe is a difficult and time consuming operation.

These numerous disadvantages of the prior art are overcome by the devices of the present invention comprising a flexible tube adapted to be inserted into the trachea, and integrally joined with a more rigid connector means for connecting the device to a source of gaseous anesthetic. The tube is provided with a cuff and inflation duct which extends along the tube to a valve member integrally joined with the connector means. The valve means is adapted to control air flow into and out of the cuff and is conveniently operated by the physician for inflating and deflating the cuff.

A better understanding of the present invention and its many advantages will be had by referring to the accompanying drawings in which:

FIG. 1 is a perspective view of an endotracheal tube constructed in accordance with the present invention, including an inflation cuff and a valve control means therefor;

FIG. 2 is a side view, in section, of portions of the en dotracheal tube illustrated in FIG. 1;

FIG. 3 is a sectional view taken on line 3--3 of FIG. 1

illustrating one embodiment of the valve control means;

FIG. 4 8 are partial sectional views, similar to FIG. 3, of other embodiments of the valve control means;

FIG. 9 is a partial sectional view, similar to FIG. 2, showing still another embodiment of the valve control means;

FIG. 10 is a sectional view taken on line 1010 of FIG. 9;

FIG. 11 is a partial side view ofa connector member for use in the present invention including yet another embodiment of the valve control means;

FIG. 12 is a sectional view taken on staggered section line 12--12 ofFIG.11;

FIG. 13 is a sectional view similar to FIG. 12 showing the valve control mechanism in another position thereof;

FIG. 14 is a sectional view taken on line 1414 of FIG. 14;

FIG. 15 is a sectional view taken on line 15-15 of FIG. 12;

FIG. 16 is a partial sectional view, similar to FIG. 2, of another embodiment of the present invention; and

FIG. 17 is a sectional view taken on line l717 of FIG. 16.

Referring to the drawing in detail, and initially to FIG. 1 thereof, it will be seen that endotracheal tube 30 embodying the present invention comprises flexible tube 32, whose proximal end portion 34 receives and is connected to the distal portion 35 of connector member 36. Connector 36 is formed with opening 15 through which access is granted to proximal portions of tube 32 for endotracheal toileting. Closure member 16 for opening 15 is secured to connector member 36 by flexible attaching means 17 to prevent inadvertent loss of member 16. Connector 36 also has fitting 14 formed integrally therewith for connection to a source of anesthetic.

Tube 32 is provided with inflation cuff 38 at its distal portion 40, which cuff surrounds the periphery of the tube and defines chamber 42 therebetween, as seen in FIG. 2. Cuff 38 is made of a relatively thin flexible material such as rubber or plastic. After tube 32 is inserted in the trachea, inflation air is supplied to chamber 42, as more fully described hereinafter, to inflate the cuff in order to retain the tube in the desired position within the trachea. To supply inflation air to cuff 38 and chamber 42, inflation duct 44 of relatively small diameter is formed in the wall of tube 32. As seen in FIG. 2, duct 44 is isolated from the interior portion of tube 32 through which anesthetic is supplied to the patient. Proximal portion 45 of duct 44 is provided with generally laterally extending duct 46 through which inflation fluid is supplied to chamber 42. Forward end 48 of duct 44 may be closed in any convenient manner, as

for example, by plug 49 to prevent loss of inflation air through end 48. Preferably plug 49 is formed ofa metal such as stainless steel so that when the tube is inserted in the trachea the plug will be visible on X rays of fluoroscope equipment to enable the physician to accurately determine its location.

It is noted that in the illustrative embodiment of the invention shown in FIG. 2, duct 44 is formed as a bore directly in the wall of tube 32 thereby providing a relatively streamlined tube construction. However, it is contemplated that duct 44 may be provided by means of a separate tube integrally joined to the periphery of tube 32, as for example by seating such tube in a groove formed in the exterior surface of tube 32.

Valve member 50, provided on connector 36, is integral therewith, and is in fluid communication with the proximal portion of duct 44, as more fully described hereinafter, in order to control the supply of air to cuff 38. Additionally, valve 50 provides a convenient mechanism for venting the collar on completion of administration of the anesthetic. Member 50 regulates air flow from a source thereof through supply duct 60 formed in connector 36, which duct provides fluid communication between valve member 50 and fluid distribution channel 52 also formed in connector 36. Channel 52 is an annular groove formed in tapered shoulder 54, which latter receives the proximal portion 34 of tube 32 and forms an airtight connection therewith.

Proximal portion 56 of tube 44 is provided with a generally laterally extending duct 58 through which air flows to duct 44 from channel 52. In this manner, a readily assembled device is provided since connector 36 may be inserted within tube 32 in any angular position without aligning fluid supply conduits 58 and 60. Accordingly, ducts 58 and 60 may be, for example, at positions 180 apart with respect to each other and yet inflation air is readily supplied to duct 44. Extreme proximal end portion 62 of tube 42 may be closed by plug member 64 in a manner similar to that of distal portion 48 or by any other convenient mechanism.

As mentioned, control valve 50 is in fluid communication with duct 60 and regulates the supply of inflation air therethrough. The valve is conveniently located on connector means 36 to facilitate control of air flow by the physician during the administration of anesthesia. Each of the embodiments of the control valve illustrated in FIGS. 7 through 17 is constructed for use with a conventional syringe which allows the physician to control the amount of air ultimately supplied to cuff 38.

Referring now to FIG. 3 of the drawings, one embodiment of control valve 50 is illustrated during operation in conjunction with syringe 66 (shown in phantom) through which inflation air is supplied to valve 50 and cuff 38. Valve mechanism 50 is located in chamber 68 formed in connector 36, in communication with supply duct 60, and includes valve structure 70 having first bore 72 in which nose 74 of syringe 66 is insertcd. Valve structure 70 has second bore 76 axially aligned with first bore 72 and provides valve seat 78 at the end of bore 72 opening towards the interior of chamber 68. Ball valve or closure element 80 is urged into engagement with valve seat 78 by spring 82 which is maintained in position between closure element 80 and wall 84 of connector 36 by nipple 86 which extends into the interior of the coiled spring. As inflation air is supplied from syringe 66 to bore 72, the pressure developed therein moves ball 80 away from seat 78 so that inflation air is supplied to the interior of chamber 68. Inflation air thence flows from chamber 68 through duct 60 to cuff 38 in the manner described above. In

, the event that the first syringe full of air is inadequate to inflate cuff 38, the physician may conveniently remove nose 74 from valve 50 to refill the syringe without loss of air from cuff 38 since valve member automatically returns to engagement with seat 78 to prevent air leakage. After the syringe is again filled the inflation process is merely repeated as described above.

Connector 36 is also provided with flexible diaphragm 88 forming one side of chamber 68. Diaphragm 88 is adapted to serve as an indicator to enable the physician to determine whether the cuff has been inflated to the required extent. Since cuff 38 is within the trachea when the device is in use, the physician is unable to visually inspect the cuff. Thus, exterior indicator 88 is provided to assist him in determining whether the cuff has been adequately inflated or if it leaks during use. Diaphragm 88 is made of a somewhat stiffer material than cuff 38, so that during the inflation process cuff 38 expands first. When cuff 38 is inflated to a point wherein the cuff is urged against the walls of the trachea, the resistance to further inflation, caused by the trachea, will increase pressure within the system. The increased pressure causes diaphragm 88 to move outwardly towards the dotted line position illustrated in FIG. 3 to provide the physician with an indication that cuff 38 is inflated. Since chamber 42 and chamber 68 are in free air communication through the ducts 42 and 60, in the event that the diaphragm does not move to the dotted line position the doctor will know that the cuff has not been satisfactorily inflated and may then discontinue use of that endotracheal tube and replace it with one operating satisfactorily. In the event that diaphragm 88 expands too far, indicating an undesirable over-inflation of cuff 38 which would injure the contacted surfaces or mucosa of the trachea, the physician may conveniently vent the collar by merely inserting a needle or other narrow instrument through bore 76 to urge ball 80 away from seat 78, thereby permitting escape of the excess air in a convenient and accurately controlled manner.

Upon completion of administration of the anesthetic, and when it becomes desirable to remove the endotracheal tube, cuff 38 must be deflated so that the tube may be withdrawn without injuring the patient. In the valve mechanism illustrated in FIG. 3, cuff 38 may be conveniently deflated by breaking diaphragm 88 so that chambers 68 and 42 are vented. To facilitate breaking of diaphragm 88, an extension tab 89 is pro vided which may be grasped by the physician for tearing the diaphragm. Since the endotracheal tubes of the present invention are intended to be disposable, this structure makes venting the collar simple and convenient with little additional expense.

Another valve construction provided for use in the present invention is illustrated in FIG. 4 and includes closure member 90 which is adapted to engage valve seat 78 to control flow of inflation air through duct 78 into chamber 68. Closure element 90 has stem portion 92 integrally formed with mounting portion 94 sealed in aperture 96 in side wall 84 of connector 36. Stem 92 is flexibly connected to and integrally formed with mounting portion 94 by generally conically shaped disc 98 connected at its apex 99 to stem 92. Disc 98 urges the stem and closure member towards valve seat 78.

Stem 92 extends beyond the surface of connector 36 so that its free end 100 may be conveniently grasped by the physician to control the position of closure member 90. In this manner, when it is desired to vent cuff 38 to remove excess air, or on completion of the surgical procedure, the physician may merely move stem 92 away from valve seat 78 so that closure member 90 occupies the dotted line position in FIG. 8. The inflation air is then vented through duct 60 and bore 76 to the atmosphere. In this embodiment, connector 38 is also provided with indicator diaphragm 88, but no tab is provided since valve control member or stem 92 provides for the venting function.

FIG. 5 illustrates yet another valve embodiment adapted for use in the present invention, and which is similar in construction to the valve structure shown in FIG. 3. The valve of FIG. 5 includes ball valve element 80 adapted to engage valve seat 78 to control the supply of inflation air through bores 72 and 76. In this case, however, spring 82 is held in compression between wall 102 formed in cavity 68 and is seated on nipple 104 formed integrally with wall 102 to maintain the position of the spring with respect to ball 80.

Wall 102 is formed with bore 106 which communicates between chamber 68 and second chamber 108. i

The latter is provided with flexible diaphragm 110, similar in construction to diaphragm 88, which serves as an inflation indicator for cuff 38. Thus, as inflation air is supplied through bores 72 and 76 from a syringe (not shown), ball 80 is moved away from valve seat 78 and the air thus supplied passes through duct 60 to cuff 38. Cuff 38 and chamber 108 are in air communication through duct 106, so that when cuff 38 is inflated and engaged with the walls of the trachea, the pressure in chambers 42 and 108 will increase sequentially, as described above, until diaphragm 110 expands and moves to its dotted line position. To vent cuff 38 in this embodiment, tab 112 is provided, similar in construction to tab 89, so that the diaphragm may be ruptured and inflation air vented through duct 106 from cuff 38 on completion of the anesthetic procedures.

Yet another valve structure suitable for use in the present invention is illustrated in FIG. 6 showing connector 36 provided with a pair of annular chambers 116 and 118 separated by annular wall 120. Wall 120 has aperture 122 therein formed by tapered edge 123 which provides valve seat 124. Resilient closure member 126, preferably ofa material such as rubber, is

constrained within chamber 118 between wall 128 of connector 36 and valve seat 124. Control element 130 is slidably mounted within chamber 116 and has nipple 132 formed integrally therewith which extends through bore 122 and engages closure member 126. Connector 36 adjacent chamber 116 has an extension 133 including groove 134 formed on the exterior surface thereof. Groove 134 cooperates with nipple 136, formed on flange 138 of control element 130, to guide the control element during sliding movement in chamber 116 and to prevent inadvertent removal of element 130 from connector 36. Bore 140 is formed in flange 138 to vent chamber 142, formed between the flange and the surface 144 of extension 133, in order to avoid creation of a pressure pocket in chamber 142 which would resist movement of element 130.

Control element 130 has interior bore 72 which is adapted to receive the forward end of a syringe for supplying inflation air to the device and second bore 76' which provides air communication between bore 72 and chamber 116. When the physician inserts the syringe (not shown) within bore 72, he simply urges control member 130 towards closure member 126 whereby nipple 132 compresses member 125 to move it from valve seat 124 and thus permit the passage of inflation air from the syringe through duct 76' to chamber 116 into chamber 118 and supply duct 60. In this manner, the multiple springs and valve members of the prior embodiments are eliminated and a single simple closure member which maintains itself against the valve seat is provided. Indicator diaphragm 145 is provided on connector 36 for indicating when cuff 38 is inflated, as in the prior embodiments. In addition, indicator 145 may have tab 146 for rupturing the diaphragm on completion of the administration of anesthetic so that the inflation air within cuff 38 and chamber 118 may be vented therefrom to facilitate removal of the endotracheal tube.

FIGS. 7 and 8 illustrate a pair of closure valves 150 and 150 respectively, which are similar in construction and operation and like numerals in each of the Figures represent like parts. In each of these embodiments, connector means 36 is provided with a pair of chambers 151 and 152, separated by annular wall 153 having duct 154 therethrough. Duct 154 defines valve seat 155 on the side of wall 153 facing chamber 151. Valve control member 156 is slidably mounted within chamber 152 and includes stem portion 157 extending through bore 154. Stem 157 in valve mechanism 150 has semispherical closure element 158 mounted thereon for engaging valve seat 155 to prevent air flow through bore 154, whereas valve mechanism 150 has fiat sealing disc 160 mounted thereon, for example by a friction fit. In each case, spring 162 is held in compression between control member 156 and wall 153 within chamber 152. As seen in the drawings, spring 162 maintains the closure elements in engagement with valve seat 155 to prevent air flow therethrough. Control member 156 is provided with bore 72 which is adapted to receive the forward end of a syringe (not shown) for supplying air to the device. Further, bore 172 provides fluid communication between bore 72 and chamber 152.

Connecting means 36 of these embodiments is formed to facilitate supplying air to a syringe during the inflation operation, without need for the physician to remove the syringe from the device. To accomplish this end, groove 164 is formed in valve mounting portion 166 of connecting member 36 to provide a flow path for ambient air along the exterior surface of control member 156. The latter has a laterally extending bore 168 which provides an air flow path between groove 164 and bore 72. Thus, when a syringe is inserted within control member 156, a supply of ambient air is available to be drawn into the syringe by the physician. The syringe frictionally engages the inner surface of bore 72 and is thus held in spaced relation to wall 170. Once the syringe is filled with air, the physician merely further urges the syringe, and thus member 156, towards wall 153. This moves bore 168 out of communication with groove 164 and opens the valve by moving closure member 158 away from valve seat 155 so that air within the syringe may be supplied to collar 38. With this construction, the physician may readily refill the syringe by simply relieving pressure on member 156 so that bore 168 is again in communication with groove 164. Thus, the inconvenient and time-consuming step of removing the syringe from the valve for refilling is avoided.

Chamber 151 of valve mechanism 150 is also provided with diaphragm 174, similar in construction to the diaphragms previously discussed, which indicates when cuff 38 is filled. This diaphragm is also frangible so that cuff 38 and chamber 151 may be conveniently vented on completion of the anesthesia procedures. In valve mechanism 150, diaphragm 174' is positioned at a somewhat different location, forming a different wall portion of chamber 151 than diaphragm 174.

In FIG. 9 yet another embodiment of the valve structure which may be used in the present invention is illustrated in a sectional view similar to FIG. 2. In this case, connector 36 is provided with extension tube 175 in which valve element 176 is mounted. Element 176 has axially aligned bores 72, 76 therein. Bore 76 provides valve seat 78 which is adapted to be engaged by closure ball element 80 held against the valve seat by spring 82, which is held in compression between the ball and peripheral wall 178 of connecting means 36. Air supplied from a syringe inserted in bore 72 moves ball 80 away from valve seat 78 to open the valve and to permit air flow therethrough. End 180 of element 176 adjacent wall 178 is provided, as seen in FIG. 14, with a plurality of passages 182 extending radially therefrom which provide flow paths for inflation air to annular groove 184 formed therein. Groove 184 communicates with duct 60 to provide air flow to cuff 38 (not shown). By this construction, accurate alignment of duct 60 with the fluid port of the control valve is not required. The valve may be inserted within member 174 in any angular position and yet air supplied thereto will flow through the valve structure and into duct 60.

In the embodiment of the device illustrated in FIG. 9, inflation indicator 186, which comprises an annular sheet of flexible material fixed in air sealing relation at its edges 188 to connector 36 and tube 32, is provided. Sheet 186 defines annular chamber 190 about the periphery of the device. Fluid distribution groove 58 in connector 36 is provided with laterally extending duct 192 through which inflation air is supplied to chamber 190. In this manner chamber 42 formed by cuff 38 is in air communication with chamber 190 so that sheet 186 will expand to give an indication to the physician utilizing the device that cuff 38 has been inflated.

As in the prior embodiments, the indicator device may be formed ofa frangible material so that sheet 186 may be conveniently ripped from the device to vent fluid contained within cuff 38 and duct 60 on completion of the anesthetic procedures.

Another embodiment of valve means adapted for use in the present invention is shown in FIG. 11. Valve mechanism 200 is illustrated in which an additional control is provided for the valve wherein the position of the valve structure may be varied so that the three operations of intaking air, inflating the cuff, and exhausting the air may be performed while the syringe is maintained within the valve. As seen more clearly in FIG. 12, the valve structure of valve 200 is similar to the structure of valve means illustrated in FIG. 3, and thus, like numerals have been used therein to represent like parts. In this case, however, a valve body 202 is provided with enlarged flange 204 surrounding bore 72. Body 202 is rotatably mounted within connector means 36 by annular rib 206 which mates with annular groove 208 formed on the interior wall 210 of chamber 68.

Flange 204 has an inwardly extending stud 212 which is adapted to engage stop members 214 located at three evenly spaced positions about arcuate groove 216 formed on surface 218 of connector means 36. Groove 216, as seen in FIG. 14, extends arcuately approximately 180 and stop members 214 are evenly spaced therealong to correspond with the three operative positions of the valve, that is, the intake, inflate and exhaust positions.

Valve body 202 has longitudinally extending groove 220 therein which communicates with laterally extending bore 222 formed in its peripheral wall. Another generally L-shaped bore 224 is formed in connector 36, which bore communicates with bore 222 when body 202 is in the intake position (FIGS. 13 and 15) so that an air flow path is defined from the exterior of the connector means 36 to the interior of bore 72. In this position, a syringe (not shown) whose forward portion is inserted within bore 72 may be readily inflated by the physician. When the syringe is thus inflated, the physician merely rotates valve body 202 by grasping flange 204 and turning the entire valve body to the second, or inflate position wherein bore 220 is moved out of communication with bore 224 and thus is sealed from the exterior connector 36. The physician then operates the syringe to force the air contained therein against ball to move the ball, against the urging force of spring 82, away from seat 78 to permit air through duct 60 to cuff 38.

Upon completion of the anesthesia procedure, the physician further rotates valve body 202 to the third or exhaust position wherein the valve is adapted to vent air from within chamber 68 and cuff 38. In order to vent chamber 68 and cuff 38, element 202 is provided with groove 226 formed on the periphery thereof and located approximately away from groove 220. Thus when flange 204 is rotated to the exhaust position, groove 226 is placed in alignment with groove 224 (as seen in FIG. 13). In this way a flow path is provided from the interior of chamber 68 to the exterior of connecting means 36. In this configuration, duct 222 is positioned against an annular wall of chamber 68 so that air cannot escape therefrom. Thus, the physician need not remove the syringe from bore 72 at any time; the syringe remains conveniently available for use if additional air must be supplied to cuff 38.

In this embodiment, indicator diaphragm 228, which is similar in construction to previously discussed diaphragms and forms a wall portion of chamber 68 to provide an indication of whether or not cuff 38 has been inflated as desired, is provided.

A somewhat modified endotracheal tube connector 250, adapted for use in the present invention, is illustrated in FIG. 16. As seen therein, connector 250 includes a fitting 252 formed integrally therewith for connection to a source of anesthetic and also includes a tapered anterior portion 254 adapted to receive the posterior portion of flexible tube 256. Inner bore 258 of anterior connector portion 254 includes an undercut section 260 defining an annular shoulder 262, which undercut portion is adapted to receive proximal portion 263 of tube 256 with tube end 264 abutting against shoulder 262.

As in the prior embodiments, the distal portion of tube 256 is provided with an inflation cuff (not shown) to which air is supplied through inflation duct 266 formed in the wall of the tube. Duct 266 is isolated from the interior portion of tube 256 and opens to an annular groove 268 which constitutes a plenum chamber for supplying inflation fluid through duct 266 to the cuff. Proximal portion 270 of duct 266 is closed in any convenient manner, as for example, by plug 272 to prevent loss of inflation air through end 270.

Valve member 274, more fully described hereinafter, is mounted on connector 250 at the junction of fitting 252 and distal portion 254 and provides a convenient mechanism for controlling the supply of air through duct 266 to the cuff. Valve 274 regulates air flow from a source thereof, such as a syringe 276 shown in phantom in FIG. 17, through a supply duct 278 formed in connector 250, which duct provides air communication between valve member 274 and groove 268. It is noted that by the above described construction, the endotracheal tube of the present invention is readily assembled since tube 256 may be inserted within connector 250 in any angular position, without the necessity of aligning or keying ducts 266 and 278. Accordingly, these ducts may be at positions 180 apart with respect to each other and yet inflation air is readily supplied to duct 266.

Valve mechanism 274 is located in chamber 280 formed in connector 250. Chamber 280 communicates with duct 278 and through bore 282, with bore 284 in which nose 286 of syringe 276 is inserted. Bore 282 defines valve seat 288 at one end thereof adjacent chamber 280. Closure element 290, which includes a generally conically shaped main body portion 292 is positioned within chamber 280 and is adapted to prevent air flow through duct 282 by the sealing engagement of the periphery of body portion 292 with valve seat 288. Spring 294, held in compression between body portion 292 and end wall 295 of chamber 280 normally urges closure element 290 against valve seat 288 to prevent air flow through duct 282. Closure element 290 includes stem portion 296, formed integrally with main body portion 290, which stem extends through duct 282 into bore 284. Stem 296 is adapted to be engaged by the front end of nose 286, so that the physician may open and close valve mechanism 276 by merely urging the syringe against or away from stem 296. It is noted that stem 296 is of somewhat smaller diameter than bore 282 so that air may freely flow through that bore when closure body portion 292 is moved away from seat 288 and against spring 294 by the engagement of syringe 276 with stem 296. Further, stem 296 and bore 282 are offset somewhat with respect to the longitudinal axis of bore 284 so that stem 296 is engaged with a solid portion of syringe nose 286 and does not interfere with air flow through the syringe discharge port 298.

It is thus seen that air within syringe 276 is conveniently supplied to chamber 280 and from that chamber flows through duct 278, chamber 268 and duct 266 to the inflation cuff at the anterior portion of tube 256. In the event that the first syringe full of air is inadequate to inflate the cuff, the physician may conveniently remove nose 286 from bore 284 to refill the syringe without loss of air from the cuff, since valve member 290 automatically returns to engagement with seat 280 to prevent air leakage. Thereafter, the inflation process is merely repeated.

Valve mechanism 274 is also provided with flexible diaphragm 275 that is adapted to serve as an indicator to enable the physician to determine whether the cuff has been inflated to the required extent. As seen in FIG. 17, the annular exterior wall 300, defining chamber 280, is provided with an annular groove 302 in which is seated elastic edge 304 of diaphragm 275. Removable end wall 295 of chamber 280 is provided with a port 306 which provides air communication between chamber 280 and chamber 308 defined by diaphragm 275. The latter, formed in this embodiment in a manner similar to a balloon i.e., having a rolled edge portion defining edge 304, is made of somewhat stiffer material than the cuff so that the cuff inflates to the desired extent before diaphragm 275 expands in the same manner as the diaphragms of the previously discussed embodiments.

To deflate the cuff in this embodiment of the endotracheal tube, diaphragm 275 may be removed, as by slipping edge 304 out of groove 302, or a needle or other narrow instrument may be inserted through bore 84 to engage stem 296 and move body portion 292 away from seat 288, thereby permitting escape of air from the cuff.

It is thus seen that a convenient means has been provided for controlling the supply and venting of inflation air for endotracheal tubes. This construction avoids the use of an inflation cufi such as those in prior devices having relatively poor sealing members or requiring the use of hypodermic needles for supplying the inflation air to the cuff. The valve structure is conveniently located on the connecting means and positioned within reach of the anesthesiologist and provides an indication to the physician of whether or not the cuff in the trachea has been inflated to the desired extent.

Although numerous illustrative embodiments of the invention have been described herein with reference to the accompanying drawings, it is to be understood that the invention is not limited to those precise embodiments, and that various changes and modifications may be effected therein by one skilled in the art without departing from the scope or spirit of this invention.

What is claimed is:

l. A device for the endotracheal administration of a gaseous anesthetic comprising, a flexible tube for insertion into the trachea, connector means operably connected at one end to the proximal portion of said tube and adapted to be connected at its other end to a source of anesthetic, an inflatable cuff formed of a flexible material integrally joined with and surrounding the periphery of said tube adjacent the distal portion thereof, said tube having an inflation duct isolated from the interior thereof and extending from said connector means to said cuff for supplying inflation air to said cuff, a valve assembly in said connector means in air communication with said inflation duct for controlling the supply of inflation air to said cuff, said valve assembly including first and second air chambers in fluid communication with each other, said first air chamber being adapted to receive an instrument inserted therein for supplying inflation air to said valve assembly, said second air chamber being in fluid communication with said duct and providing a valve seat in said valve assembly downstream of said first air chamber, a valve closure element adapted to engage said valve seat to prevent air flow downstream thereof, and resilient means operably engaged with said closure element for urging said element against said valve seat;

said connector means including a wall portion having an opening therein providing communication between said valve assembly and the atmosphere; and,

inflatable pressure indicator means formed of a manually frangible flexible material comprising a diaphragm secured to said connector means and closing said wall opening, said indicator means being formed of a flexible material stiffer than the material forming said cuff whereby upon the supply of air to said cuff through said valve assembly, said cuff expands prior to inflation of said indicator means, until further inflation of said cuff is prevented by engagement of said cuff with the walls of the trachea, whereupon continued supply of air to said cuff increases the pressure therein causing inflation of said indicator means, which thereby provides an indication that said cuff is fully inflated, said diaphragm having an operator engageable tab for tearing of said diaphragm to exhaust air from said cuff upon completion of the endotracheal procedure.

2. A device as in claim 1 wherein said connector has a toileting opening therein in generally axial alignment with said tube and means for selectively opening and closing said toileting opening.

3. A device as in claim 1 wherein said flexible tube and connector means are separate elements integrally joined.

4. A device as in claim 3 wherein said connector means has an axially tapered distal portion, and said proximal tube portion axially receives said tapered connector portion to form an integral connection therewith.

5. A device as in claim 4 wherein said distal portion of said connector means has an annular peripheral groove in communication with said valve assembly and forms a portion of the flow path of said inflation air, said tube having a generally transversely extending bore therein adjacent the proximal portion thereof providing communication between said inflation duct and said groove when said distal connector portion is received in said proximal tube portion.

6. A device as in claim 1 wherein said closure element comprises a ball and said resilient member comprises a spring element operably engaged between said ball and a wall portion of said connector means to urge said ball against said valve seat.

7. A device as in claim 1 wherein said resilient means comprises a resilient wall member forming a portion of said connector means, and said device further includes a control member operably connected to said resilient wall portion and to said closure element whereby said closure element is urged against said valve seat by said wall portion.

8. A device as in claim 7 wherein said control member extends through said resilient wall portion and is adapted to be moved outwardly thereof to move said closure element away from said valve seat for venting said cuff.

9. A device as in claim 1 wherein said connector means is provided with a wall separating said first and second air chambers and having an aperture therein providing air communication between said chambers, and wherein said valve assembly includes a tubular body slidably received in said first chamber, a valve control member connected to said body at one end thereof and extending through said aperture, said valve closure element being fixed to the other end of said control member within said second air chamber and being adapted to close said aperture to prevent air flow between said chambers, and said resilient means comprising a compression spring in said first chamber operably engaged between said body and said chamber separating wall for urging said closure element into engagement with said wall in said second air chamber to close said aperture.

10. A device as in claim 9 wherein said first connector chamber has a longitudinal groove formed therein and said body has a transverse bore therein adapted to communicate with said groove, whereby said groove and said bore provide an intake path for inflation air to a syringe inserted in said body in a first position thereof, said bore being moved out of communication with said groove in a second position of said body wherein said syringe and said body are moved towards said wall to open said aperture for introduction of inflation air to said cuff.

11. A device as in claim 1 wherein said valve assembly includes a tubular member rotatably mounted in said connector means and having a transverse bore therein, said connector means having a longitudinal groove therein communicating at one end with said transverse bore and at its opposed end with the atmosphere, whereby a syringe inserted in said first valve air chamber is adapted to receive ambient air for inflating said cuff.

12. A device as in claim 11 wherein said tubular member and said connector means include cooperating detent members for maintaining said tubular member in a plurality of angular positions within said connector means, whereby in one of said positions said groove and said transverse bore are in air communication and in the remainder of said positions said groove and said transverse bore are out of communication to prevent air flow into and out of said connector means.

13. A device as in claim 12 wherein said tubular member has a longitudinal groove on the periphery thereof adapted to be positioned in air communication with said groove in said connector means for venting said collar when said tubular member is in another of said angular positions.

16. A device as in claim 1 wherein said closure element includes a main body portion adapted to engage said valve seat and a stem portion extending through said second air chamber into said first air chamber, said stem being positioned for operative engagement with said instrument, whereby movement of said instrument into said first air chamber moves said main body portion away from said valve seat. 

1. A device for the endotracheal administration of a gaseous anesthetic comprising, a flexible tube for insertion into the trachea, connector means operably connected at one end to the proximal portion of said tube and adapted to be connected at its other end to a source of anesthetic, an inflatable cuff formed of a flexible material integrally joined with and surrounding the periphery of said tube adjacent the distal portion thereof, said tube having an inflation duct isolated from the interior thereof and extending from said connector means to said cuff for supplying inflation air to said cuff, a valve assembly in said connector means in air communication with said inflation duct for controlling the supply of inflation air to said cuff, said valve assembly including first and second air chambers in fluid communication with each other, said first air chamber being adapted to receive an instrument inserted therein for supplying inflation air to said valve assembly, said second air chamber being in fluid communication with said duct and providing a valve seat in said valve assembly downstream of said first air chamber, a valve closure element adapted to engage said valve seat to prevent air flow downstream thEreof, and resilient means operably engaged with said closure element for urging said element against said valve seat; said connector means including a wall portion having an opening therein providing communication between said valve assembly and the atmosphere; and, inflatable pressure indicator means formed of a manually frangible flexible material comprising a diaphragm secured to said connector means and closing said wall opening, said indicator means being formed of a flexible material stiffer than the material forming said cuff whereby upon the supply of air to said cuff through said valve assembly, said cuff expands prior to inflation of said indicator means, until further inflation of said cuff is prevented by engagement of said cuff with the walls of the trachea, whereupon continued supply of air to said cuff increases the pressure therein causing inflation of said indicator means, which thereby provides an indication that said cuff is fully inflated, said diaphragm having an operator engageable tab for tearing of said diaphragm to exhaust air from said cuff upon completion of the endotracheal procedure.
 2. A device as in claim 1 wherein said connector has a toileting opening therein in generally axial alignment with said tube and means for selectively opening and closing said toileting opening.
 3. A device as in claim 1 wherein said flexible tube and connector means are separate elements integrally joined.
 4. A device as in claim 3 wherein said connector means has an axially tapered distal portion, and said proximal tube portion axially receives said tapered connector portion to form an integral connection therewith.
 5. A device as in claim 4 wherein said distal portion of said connector means has an annular peripheral groove in communication with said valve assembly and forms a portion of the flow path of said inflation air, said tube having a generally transversely extending bore therein adjacent the proximal portion thereof providing communication between said inflation duct and said groove when said distal connector portion is received in said proximal tube portion.
 6. A device as in claim 1 wherein said closure element comprises a ball and said resilient member comprises a spring element operably engaged between said ball and a wall portion of said connector means to urge said ball against said valve seat.
 7. A device as in claim 1 wherein said resilient means comprises a resilient wall member forming a portion of said connector means, and said device further includes a control member operably connected to said resilient wall portion and to said closure element whereby said closure element is urged against said valve seat by said wall portion.
 8. A device as in claim 7 wherein said control member extends through said resilient wall portion and is adapted to be moved outwardly thereof to move said closure element away from said valve seat for venting said cuff.
 9. A device as in claim 1 wherein said connector means is provided with a wall separating said first and second air chambers and having an aperture therein providing air communication between said chambers, and wherein said valve assembly includes a tubular body slidably received in said first chamber, a valve control member connected to said body at one end thereof and extending through said aperture, said valve closure element being fixed to the other end of said control member within said second air chamber and being adapted to close said aperture to prevent air flow between said chambers, and said resilient means comprising a compression spring in said first chamber operably engaged between said body and said chamber separating wall for urging said closure element into engagement with said wall in said second air chamber to close said aperture.
 10. A device as in claim 9 wherein said first connector chamber has a longitudinal groove formed therein and said body has a transverse bore therein adapted to communicate with said groove, whereby said groove and said bore provide an intake path for inflation air to a syringe inserted in said body in a first position thereof, said bore being moved out of communication with said groove in a second position of said body wherein said syringe and said body are moved towards said wall to open said aperture for introduction of inflation air to said cuff.
 11. A device as in claim 1 wherein said valve assembly includes a tubular member rotatably mounted in said connector means and having a transverse bore therein, said connector means having a longitudinal groove therein communicating at one end with said transverse bore and at its opposed end with the atmosphere, whereby a syringe inserted in said first valve air chamber is adapted to receive ambient air for inflating said cuff.
 12. A device as in claim 11 wherein said tubular member and said connector means include cooperating detent members for maintaining said tubular member in a plurality of angular positions within said connector means, whereby in one of said positions said groove and said transverse bore are in air communication and in the remainder of said positions said groove and said transverse bore are out of communication to prevent air flow into and out of said connector means.
 13. A device as in claim 12 wherein said tubular member has a longitudinal groove on the periphery thereof adapted to be positioned in air communication with said groove in said connector means for venting said collar when said tubular member is in another of said angular positions.
 14. A device as in claim 1 wherein said connector means has an axially tapered anterior portion including an annular shouldered recess axially receiving said posterior tube portion.
 15. A device as in claim 14 wherein said tube has an annular groove on the periphery of its posterior portion, said groove communicating with said inflation duct and said valve assembly to provide air communication therebetween.
 16. A device as in claim 1 wherein said closure element includes a main body portion adapted to engage said valve seat and a stem portion extending through said second air chamber into said first air chamber, said stem being positioned for operative engagement with said instrument, whereby movement of said instrument into said first air chamber moves said main body portion away from said valve seat. 